Job Description Summary
Familiarity with Good Laboratory Practices (GLP) and cGMP standard and understanding of FDA regulations, especially 21 CFR Part 211 for pharmaceutical QC labs.Independently conduct tests
• Analyze data and generate reports
• Handle complex tasks and projects
• Ability to handle out-of-specification (OOS) investigations, data integrity, and documentation practices.
Job Description
Required Analytical Experience:
- Analyst must having the Hands-on experience in analysis of Finished Products, Raw Materials, Stability Samples, and In-Process Samples (both wet chemistry and instrumental methods).
- Proficient in calibration and operation of QC instruments including:
- HPLC
- Dissolution Apparatus
- FT-IR
- UV-Visible Spectrophotometer
- Karl Fischer Titrator
- Friability Tester
- Disintegration Tester
- Ensures laboratory compliance with Good Laboratory Practices (GLP).
Instrument Handling Expertise:
- HPLC (Waters)
- GC (Agilent)
- UV/Vis Spectrophotometer
- Dissolution Apparatus
- Karl Fischer Titrator
- FT-IR Spectrometer
- Particle Size Analyzer
- Differential Scanning Calorimeter (DSC) & Thermogravimetric Analyzer (TGA)
- Analytical Balance
- pH Meter & Conductivity Meter
- Disintegration Test Apparatus
- Friability Test Apparatus
Required Analytical Experience:
- Analyst must having the Hands-on experience in analysis of Finished Products, Raw Materials, Stability Samples, and In-Process Samples (both wet chemistry and instrumental methods).
- Proficient in calibration and operation of QC instruments including:
- HPLC
- Dissolution Apparatus
- FT-IR
- UV-Visible Spectrophotometer
- Karl Fischer Titrator
- Friability Tester
- Disintegration Tester
- Ensures laboratory compliance with Good Laboratory Practices (GLP).
Instrument Handling Expertise:
- HPLC (Waters)
- GC (Agilent)
- UV/Vis Spectrophotometer
- Dissolution Apparatus
- Karl Fischer Titrator
- FT-IR Spectrometer
- Particle Size Analyzer
- Differential Scanning Calorimeter (DSC) & Thermogravimetric Analyzer (TGA)
- Analytical Balance
- pH Meter & Conductivity Meter
- Disintegration Test Apparatus
- Friability Test Apparatus
Top Skills
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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